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Prostate Cancer Deaths [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years. ]

Prostate cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.

Prostate Cancer Death Rates [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years. ]

Prostate cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.

Original Primary Outcome Measures ICMJE

Not Provided

Change History

Current Secondary Outcome Measures ICMJE (submitted: June 19, 2014)

Deaths From All Causes [ Time Frame: Events through 13 years of follow-up or through December 31, 2009. ]

Deaths from all causes were compared between the prostate cancer screening arm and the usual care arm.

Death Rates From All Causes [ Time Frame: Events through 13 years of follow-up or through December 31, 2009. ]

Deaths from all causes were compared between the prostate cancer screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.

Prostate Cancer Incidence [ Time Frame: Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years. ]

This clinical trial studies whether screening methods used to diagnose cancer of the prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening tests may help doctors find cancer cells early and plan better treatment for prostate cancer.

ARM II (Prostate Screening): Participants undergo blood sample collection for PSA analysis at baseline and annually for 5 years. Serum that is not used in the study will be stored in an NCI biorepository. Participants also undergo a DRE at baseline and annually for 3 years. A scheduling and tracking procedure is implemented to ensure regular attendance at repeat screens for participants screened negative or for those who are designated suspicious or positive at screening but for whom subsequent diagnostic procedures do not reveal prostate cancer (follow-up diagnostic procedures are through their own medical care environment). Participants diagnosed with prostate cancer via a screening test are referred for treatment in accordance with current accepted practice for appropriate stage of disease, patient age, and medical condition; a procedure is provided for contact with qualified medical personnel to insure appropriate therapy.

Participants complete a Dietary Questionnaire (DQX) at baseline and DHQ at year 3. An Annual Study Update (ADU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident prostate cancers as all deaths that occur among both screened and control subjects during the trial.

After completion of screening, participants are followed up for at least 13 years.

Participants undergo blood sample collection for PSA analysis at baseline and annually for 5 years. Serum that is not used in the study will be stored in an NCI biorepository. Participants also undergo a DRE at baseline and annually for 3 years. Participants complete a DQX at baseline and DHQ at year 3. An ADU (previously referred to as the PSH questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident prostate cancers as all deaths that occur among both screened and control subjects during the trial.

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Active, not recruiting

Actual Enrollment ICMJE (submitted: June 19, 2014)

76685

Original Enrollment ICMJE

Not Provided

Study Completion Date ICMJE

Not Provided

Actual Primary Completion Date

May 21, 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Exclusion Criteria:

Men who at the time of randomization are less than 55 or greater than or equal to 75 years of age

Individuals undergoing treatment for cancer at this time, excluding basal-cell and squamous-cell skin cancer

Individuals with known prior cancer of the colon, rectum, lung, prostate

This includes primary or metastatic PLCO cancers

Individuals with previous surgical removal of the entire colon, one lung, or the entire prostate

Individuals who are participating in another cancer screening or cancer primary prevention trial

Males who have taken Proscar/Propecia/finasteride in the past 6 months

NOTE: Individuals who are already enrolled in the trial when their physician prescribes finasteride are not prevented from taking this medication. As a result, these participants will continue to be screened and followed just as those participants who are not on finasteride.

NOTE: Men who are taking Tamoxifen are not excluded from any part of the PLCO Screening Trial.

Individuals who are unwilling or unable to sign the informed consent form

Males who have had more than one PSA blood test in the past three years

Individuals who have had a colonoscopy, sigmoidoscopy, or barium enema in the past three years

Sex/Gender ICMJE

Sexes Eligible for Study:

Male

Ages ICMJE

55 Years to 74 Years (Adult, Older Adult)

Accepts Healthy Volunteers ICMJE

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects